The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery

NCT05094843 | Recruiting

• 1 other identifier: R21087
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer surgery causes significant changes in the small circulation as well as changes in the intrathoracic anatomy. The effects of lung cancer surgery on electrocardiography and the cardiac stress associated with the procedures have not been previously extensively studied. The aim of the present study is to ascertain whether modern mini-invasive lung cancer surgery causes changes in the electrocardiogram, and whether these changes are transitory during short-term follow-up. Furthermore, the study aims to describe whether lung cancer surgery causes significant cardiac stress detectable by intraoperative electrocardiography.

Conditions

Lung Cancer; Surgery; Arrhythmia; Myocardial Ischemia

Keywords

Lung cancer; Electrocardiogram; Arrhythmia

Outcome Measures

Primary Outcomes (13)

• Postoperative electrocardiographic p-, R-, and T-wave amplitude changes

  Amplitude changes in the 12-lead rest electrocardiography in millimeters, analyzed daily postoperatively.

  2 weeks

• Postoperative QRS-duration

  The duration of the QRS-complex in milliseconds in the electrocardiogram, measured daily postoperatively using 12-lead rest electrocardiogram.

  2 weeks

• Postoperative PQ-delay

  Changes in the PQ-delay in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.

  2 weeks

• Postoperative QT-interval

  The duration of QT-interval in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.

  2 weeks

• The postoperative incidence of new bundle branch blocks

  New complete or partial bundle branch blocks, such as RBBB, in the 12-lead rest electrocardiogram.

  2 weeks

• Postoperative ST-level changes

  ST-level changes in millimeters in the 12-lead rest electrocardiogram

  3 days

• Postoperative P-wave, QRS-complex, and T-wave axle changes

  The occurrence and type of P-wave, QRS-complex, and T-wave axle changes in the postoperative 12-lead rest electrocardiogram

  2 weeks

• Postoperative heart rate

  Postoperative heart rate variability in continuous electrocardiographic monitoring

  1 week

• Postoperative arrhythmias

  Arrhythmia rate as well as their type during the early postoperative period detected by continuous electrocardiogram monitoring

  1 week

• Perioperative ST-level changes

  The occurrence, duration (in minutes) as well as the magnitude (in millimeters) of perioperative ST-elevation or depression in the continuous perioperative electrocardiographic monitoring.

  1 day

• Perioperative heart rate variability

  Heart rate levels perioperatively in the continuous perioperative electrocardiographic monitoring.

  1 day

• Perioperative arrhythmias

  The occurrence and type of perioperative arrhythmias, such as atrial fibrillation or flutter, or ventricular tachycardia in the perioperative electrocardiographic monitoring.

  1 day

• Perioperative R- and T-wave amplitude changes

  The amplitude (in millimeters) of possible R- and T-wave amplitude changes in the perioperative electrocardiographic monitoring.

  1 day

Secondary Outcomes (2)

• Postoperative air leak

  1 week

• Need for reoperation

  1 week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective, curatively aimed, primary lung cancer surgery using mini-invasive surgical techniques.

You may qualify if:

• Adult patients scheduled for elective lung cancer surgery
• Willing to participate in the study
• Curatively aimed surgery
• Preoperative decision for mini-invasive surgery

You may not qualify if:

• Participation in any other clinical trial
• Previous chronic or paroxysmal atrial fibrillation or atrial flutter
• Cardiac pacemaker
• History of cardiac conduction disturbances including bundle branch blocks
• History of cardiac ablation procedures
• History of previous surgery in the thoracic area including open heart surgery
• Preoperatively anticipated need for concomitant thoracic wall resection
• Preoperatively anticipated need for open surgery

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Heart Hospita, Tampere University Hospital

Tampere, Pirkanmaa, 33580, Finland

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Arrhythmias, Cardiac; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Jahangir Khan

  MD, PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jahangir A Khan, MD, PhD

CONTACT

+3583311611; jahangir.khan@sydansairaala.fi

Kati Helleharju, RC

CONTACT

+358504361303; kati.helleharju@sydansairaala.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 26, 2021
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)